Ostomy Output Diversion Device

ABSTRACT

An ostomy output diversion device is used to cover and seal closely around a patient&#39;s stoma, to divert stoma effluent output through the device, into a container or reservoir, temporarily eliminating the need of an adhesive-based ostomy pouching system. The ostomy output diversion device is placed over the person&#39;s stoma, with the base ring surrounding the peristomal skin, the adjustable inner tube is retracted until the base ring is centered over the stoma, the body support strap is then placed over the device to secure it to the patient&#39;s body, the inner tube is then extended over the stoma, the patient applies the desired pressure against the skin, then secures the inner tube in place with the pressure adjustment lock. The device may also include an ostomy pouch mounting ring for attachment to an ostomy pouch, and a disposable receptacle.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application is a continuation-in-part of U.S. Ser. No.16/518,506 entitled Ostomy Output Diversion Device filed on Jul. 22,2019. All of the foregoing applications are hereby incorporated byreference in their entireties.

FIELD OF THE INVENTION

The present invention relates to a medical device designed to captureostomy effluent output without the need of an adhesive-based ostomypouching system, allowing extended periods of time without skin beingcovered, and designed to improve chronic peristomal skin conditions.

BACKGROUND OF THE INVENTION

Surgical procedures such as a colostomy, urostomy and ileostomy involvererouting of the colon or ureter so that effluent can be dischargedthrough an artificial opening formed in the ostomy patient's (alsoreferred to herein as ostomate) body. This artificial opening, called astoma, is typically located in the abdomen and may be about 0.5 to 2.5inches or more in diameter.

The new artificial opening, or stoma, made on the abdominal wall, has novoluntary sphincter control by the ostomate. Collection of involuntarywaste seepage is by a pouching system, typically comprising a pouch andbaseplate, or other receptacle attached to the ostomate's body, wherethe pouching system is disposed of after use, and replaced with a freshpouching system. Typically, such pouching systems are attached to thebody over the stoma by means of a baseplate with adhesive backing whichmust be positioned over the stoma with precision to achieve a reliableattachment and seal. It is essential that this baseplate be mounteddirectly and concentrically over the stoma and further, that it betightly secured to the body, otherwise leakage of waste onto thesurrounding skin area can occur.

The pouching system is typically replaced every 2 to 5 days, with thereplacement process typically taking 15 to 30 minutes. During thepouching system replacement process, while the pouching system isremoved and the peristomal skin is exposed, the common practice has beento first clean and dry the peristomal skin, then treat and medicate anyskin irregularities, followed by thorough drying of the skin andapplication of the new pouching system. Continued seepage of effluentand other uncontrollable factors, often cause the ostomate to hasten theprocess and apply the new pouching system prematurely, leading tofurther exacerbation of any emerging or existing skin conditions.Patients often experience acute or chronic peristomal skin conditionscaused by medical adhesive related skin injury, moisture associated skindamage, allergic reactions to ostomy supply materials, and extended weartimes with limited time to adequately treat skin before applying the newpouching system.

Attempts have been made to improve the procedures mentioned above forreplacing pouches and cleaning a stoma or fistula and surrounding areas.The following references represent some of these past attempts, and eachof the documents cited below are hereby expressly incorporated herein byreference, in their entireties:

WIPO Patent Publication Number WO2001000260 Colostomy Pump Device

A device (10) for evacuating waste product through an orifice in amammalian body, the device (10) including a chamber (11) having anirrigating means (16) for introducing an irrigating fluid into theorifice and a suction means (40) for removing the irrigating fluid andwaste products from the orifice.

U.S. Application No. 20130180294 Ostomy Device, Apparatus and System

Devices for insertion into a stoma formed in a patient's body areprovided, comprising a tube having distal and proximal ends and defininga path for movement of waste. To retain the device in the stoma and sealthe stoma, the tube includes a retention mechanism located on the distalend and/or a sealing mechanism extending along a length of the tubebetween the proximal and distal ends. Collection apparatus forcollecting waste from a patient's body also are provided, comprising awaste pouch and a connector for connecting the collection apparatus to adevice inserted into a stoma. Additionally, waste collection systems forcollecting waste from a patient's body are provided, comprising a tubefor insertion into a stoma and a waste pouch. Each system may comprise aseparate tube and waste pouch or the tube and waste pouch may be formedas an integral, inseparable component.

Canadian Patent No. CN1074687406 Stoma Drainage Bag Support Frame

The invention provides a stoma drainage bag support frame. The supportframe comprises a first annular bracket, a second annular bracket andconnecting rods, the outer diameter of the second annular bracket issmaller than the inner diameter of an opening of a drainage bag, thenumber of the connecting rods is three, the connecting rods are evenlyarranged on the first annular bracket and the second annular bracket andconnect the first annular bracket with the second annular bracket, thevertical distance between the first annular bracket and the secondannular bracket is 2-5 cm, and the second annular bracket is providedwith three convex portions, wherein the three convex portions arearranged at the joints of the connecting rods and the second annularbracket, externally protrude in a same plane with the second annularbracket and are used for fixing the bracket in a base plate ring of thestoma drainage bag. The stoma drainage bag support frame is placedbetween a drainage base plate and the drainage bag, by means of thesupport frame, damage to or necroses of a gut or an external segment ofa ureter under pressure caused by negative pressure generated bydrainage is avoided, and meanwhile, the phenomenon of liquid backflowcaused by negative pressure effect and infection of a patient areavoided, so that health of the patient is guaranteed.

Each of the devices and methods set forth above are useful, but theseadvancements also have disadvantages. It would be desirable, therefore,to provide an ostomy output diversion device that is simple to use,inexpensive to manufacture, and which provides a useful and efficientway to maintain the health and cleanliness of a patient's stoma andsurrounding skin and tissue.

BRIEF SUMMARY OF THE INVENTION

The present invention relates to a medical device designed to captureostomy effluent output without the need of an ostomy pouching system,allowing extended periods of time without skin being covered by anadhesive baseplate, and designed to improve chronic and acute peristomalskin conditions.

In a first embodiment, the ostomy output diversion device includes amain body member, the outer frame of the main body member is shaped in amanner to extend away from the body, with space between the framesupports to allow open access to the peristomal skin, allowing patientsto treat and medicate the peristomal skin, and to leave the skinuncovered for an extended period of time, an inner tube guide foraligning and supporting an inner tube, an inner tube member positionedthrough the center of the main body member and inner tube guide andadjustable to allow movement within the main body member and inner tubeguide, a stoma-sized adapter attached to the bottom end of the innertube member and sized to fit over the stoma, a sealing ring attached tothe bottom of the stoma-sized adapter to prevent effluent from seepingbetween the adapter and adjacent skin, a pressure adjustment lock toapply adequate pressure between the stoma-sized adapter and the adjacentskin during application, an effluent draining tube attached to the draintube connector on the distal end of the inner tube, the opposite end ofthe effluent draining tube leading to a reservoir container to containeffluent output, with an adjustable body support strap used to securethe device to the body during application.

DESCRIPTION OF THE DRAWINGS

These and other features, aspects, and advantages of the presentinvention will become better understood with regard to the followingdescription and accompanying drawings where:

FIG. 1 is a perspective view of one embodiment of an ostomy outputdiversion device, including a main body member, attached to a base ring,and having an inner tube member positioned through the center of themain body member, inner tube guide, and a stoma-sized adapter, with asealing ring attached, and an adjustable body support strap used tosecure the device to the body;

FIG. 2 is a perspective view to illustrate one embodiment of the ostomyoutput diversion device strapped on a person in a typical manner, and adrain tube attached to a reservoir;

FIG. 3A is a perspective view of one embodiment of the ostomy outputdiversion device, and the removable strap and ring positioned on thedevice;

FIG. 3B is a perspective, exploded view of one embodiment of the ostomyoutput diversion device, wherein the strap ring and strap are removedfrom the outer frame;

FIG. 4 is a perspective view of one embodiment of an ostomy outputdiversion device showing a body support strap used to secure the ostomyoutput diversion device to the body;

FIG. 5 is a perspective, exploded view of one embodiment of an ostomyoutput diversion device, wherein the strap ring and strap are removedfrom the outer frame, and further showing a pouch mounting ring on adistal portion of the strap ring for connection with an ostomy pouch;

FIG. 6 is a perspective view of the embodiment of an ostomy outputdiversion device shown in FIG. 5, wherein the strap ring is secured overthe outer frame, and the ostomy pouch is connected to the pouch mountingring;

FIG. 7 is a perspective view of the embodiment of an ostomy outputdiversion device shown in FIG. 5, wherein the strap ring is secured overthe outer frame, and the ostomy pouch is connected to the pouch mountingring;

FIG. 8 is a perspective view of the embodiment of an ostomy outputdiversion device shown in FIG. 5, wherein the strap ring is secured overthe outer frame, and the ostomy pouch is connected to the pouch mountingring, and wherein the apparatus is strapped onto a patient's body;

FIG. 9 is a perspective, exploded view of one embodiment of an ostomyoutput diversion device, wherein the strap ring is removably securedover the outer frame, and wherein an output adapter is attachable to thestrap ring;

FIG. 10 is a perspective view of one embodiment of an ostomy outputdiversion device, wherein the strap ring is removably secured over theouter frame, and wherein an output adapter is removably attached to thestrap ring;

FIG. 11 is a perspective view of one embodiment of an ostomy outputdiversion device, wherein the strap ring is removably secured over theouter frame, and wherein an output adapter is removably attached to thestrap ring;

FIG. 12 is a perspective view of one embodiment of an ostomy outputdiversion device, including a main body member attached to a base ring,and having an inner tube member positioned through the center of themain body member, inner tube guide, and a stoma-sized adapter with asealing ring attached thereto, and an adjustable body support strap usedto secure the device to the body, and further including an elbow memberattached to a drain tube connector, and a drainage tube extendingbetween the elbow member and a reservoir for receiving effluent;

FIG. 13 is a perspective view of another embodiment of an ostomy outputdiversion device, including a main body member attached to a base ring,and having an inner tube connected to the main body member, wherein theinner tube includes a first opening for placement over a stoma orfistula, and a second opening for attachment to a drainage channel thatmay be operatively connected to a reservoir; and

FIG. 14 is a perspective view of the ostomy output diversion deviceshown in FIG. 13.

FIG. 15 is a perspective view of the embodiment of an ostomy outputdiversion device shown in FIG. 13, wherein the strap ring is secured tothe outer frame, and wherein the apparatus is strapped onto a patient'sbody;

FIG. 16 is a perspective view of the ostomy output diversion deviceshown in FIG. 13;

FIG. 17 is a perspective view of the ostomy output diversion deviceshown in FIG. 13;

FIG. 18 is a perspective, exploded view of one embodiment of an ostomyoutput diversion device, wherein the strap ring and strap are removedfrom the outer frame, and further showing a concealing cap and tensionstraps;

FIG. 19 is a perspective, exploded view of one embodiment of an ostomyoutput diversion device, wherein the inner tube and drainage adapter areseparated from the outer frame, and further showing the strap ring andstrap removed from the outer frame, and further showing a concealing capand tension straps; and

FIG. 20 is a perspective view of one embodiment of an ostomy outputdevice showing an odor filter integral to the concealing cap.

DETAILED DESCRIPTION OF THE INVENTION

FIG. 1 illustrates an embodiment of the present invention whereby theostomy output diversion device includes a main body member 1 having abase ring 2, support members 16 attached to the base ring 2 on a firstend thereof, and an outer frame 14 attached to the support members 16 ona second end thereof. In a preferred embodiment, the outer frame 14extends away from the patient's body, with space provided betweensupport members 16 to allow open access to the peristomal skin. The basering 2 may be constructed of any suitable material, but preferably ofsoft material for skin contact comfort. In one embodiment, the base ring2 may be malleable, so that a patient may form the base ring 2 into anydesired shape or configuration to conform to the contour of his or herabdominal shape, as desired, for ease of use. In this embodiment, thebase ring 2 may be made from flexible materials, such as rubber, foam,or other suitable formable materials, and may also include a structuralwire to allow the base ring to maintain the desired configuration formedby the patient. In some embodiments, the base ring 2 may be removableand replaceable with base rings of other sizes, shapes, orconfigurations.

In a preferred embodiment, the ostomy diversion device further includesa centrally located inner tube member 3, positioned through the centerof the main body member 1 and an inner tube guide 7 that is held inplace by support spokes 15 that are attached to the inner portion of thesupport members 16. A stoma-sized adapter 4 is attached to the proximalend of the inner tube member 3 and sized to fit over the stoma orfistula, and the adapter 4 includes a sealing ring 5 that is used toprevent effluent from seeping between the stoma-sized adapter 4 andadjacent skin. The inner tube member 3 is preferably telescopic innature, and is incrementally or infinitely adjustable inwardly andoutwardly in linear fashion, in order to allow movement within the mainbody member 1. A pressure adjustment lock 6 is used to apply andmaintain adequate pressure between the stoma-sized adapter 4 and theadjacent skin during application. In use, when the base ring is placedin the proper position against a patient's skin, the inner tube member 3may be extended toward the stoma or fistula to ensure a tight fit, andthe pressure adjustment lock 6 is used to maintain the extended positionthereof. The pressure adjustment lock 6 may be disengaged andrepositioned during use, or after use, as desired.

In a preferred embodiment, the ostomy output diversion device includes aremovable body support strap 9 and strap mounting ring 10, used tosecure the ostomy output diversion device to the body duringapplication. The removable body support strap 9 may be affixed to thestrap mounting ring 10, which fits over or onto the distal portion ofthe outer frame member 14, as shown in FIGS. 3A and 3B, or the strap 9may be affixed to other portions of the device, such as the base ring 2as shown in FIG. 4. Any suitable strap means may be used to attach thedevice to a patient's body, so long as the device, and specifically thesealing ring 5 of the stoma-sized adapter 4 are held firmly in placeagainst the patient's skin, in order to prevent any effluent fromleaking therefrom.

In a preferred embodiment, the ostomy output diversion device includes adrain tube connector 8, used to connect a drain tube 12 to the distalend of the inner tube 3, and to a reservoir 13 to collect ostomy output.Essentially, a clear drainage passage is formed from the adapter 4through the inner tube 3, the tube connector 8, and into the drain tube12, so that effluent may pass unobstructed from the stoma or fistula tothe reservoir 13 without leakage from any point along the way. In apreferred embodiment, a hollow elbow joint 11 may be affixed to the tubeconnector 8 on a first side thereof, and the second side of the elbowmember 11 may be attached to the drainage tube 12 leading to thereservoir 13, as shown in FIG. 12. The elbow joint 11 may be formed intoany desired angle, and preferably is formed into an angle in the rangeof 40 to 50 degrees. This arrangement allows the drainage tube 12 toextend in any desired direction toward the reservoir 13 in a low profilemanner, rather than having the drainage tube 12 extend in linear fashionfrom the tube connector 8, which may be awkward or cumbersome in somesituations or tight spaces.

FIG. 2 illustrates an embodiment of the present invention whereby theostomy output diversion device is strapped on a person in a typicalmanner, covering and sealing over the person's stoma or fistula,allowing effluent to exit the stoma or fistula, pass through the ostomyoutput diversion device, into a drain tube 12 attached to the drain tubeconnector 8 of the ostomy output device, and into a reservoir 13 forcollecting ostomy output.

FIG. 3A illustrates an embodiment of the present invention whereby theostomy output diversion device has a body support strap 9 and strapmounting ring 10 that fits over the distal end of the outer frame 14, sothat the strap is used to secure the ostomy output diversion device tothe body during application. FIG. 3B illustrates an embodiment of thepresent invention whereby the body support strap 9 and strap mountingring 10 are removable from the ostomy diversion device.

FIG. 4 illustrates an embodiment of the present invention whereby thebody support strap 9 is integrally formed with the base ring 2 forsecuring the ostomy output diversion device to the body duringapplication.

In use, after an ostomy patient has removed a used bag and attachmentapparatus and cleaned the skin around the stoma or fistula, the patientplaces the base ring 2 firmly against his skin so that the adapter 4 ispositioned over the stoma or fistula. The patient then extends theadapter 4 inwardly toward the stoma or fistula until the sealing ring 5is firmly in place around the stoma or fistula and secured in place bythe pressure adjustment lock 6, and then affixes the strap ring 10around the distal portion of the outer frame 14 and secures the strap 9around his body. The next step includes affixing the drainage tube 12 tothe tube connector 8 (or affixing the drainage tube 12 to the elbowjoint 11, and the other side of the elbow joint 11 to the tube connector8), and connects the other end of the drainage tube 12 to a reservoir13. It should be understood that some of these steps may be combined orperformed out of the recited order without departing from the scope orthe spirit of the present invention.

This device allows the peristomal skin around the stoma to remainuncovered for extended periods of time, so that it can breathe andpotentially be treated with an ointment, salve or other topical medicaltreatment, for as long as the patient desires. Once the ostomy outputdiversion device is properly secured to the patient's body, thepatient's hands can remain free of the device, and may be used for othertasks or activities (or may simply rest) while the device is held inplace by the straps 9.

FIGS. 5-8 show another embodiment of the present invention, wherein thestrap ring 10 includes a pouch mounting ring 20 on an outer portionthereof. An ostomy pouch 22 may be removably attached to the pouch ring20 in order to receive effluent from the patient's stoma or fistulawhile the ostomy output diversion device is properly secured to apatient's body.

FIGS. 9-11 illustrate another embodiment of the present invention,wherein an output adapter 24 may be removably secured to the strap ring10 (or, alternatively, to a pouch mounting ring 20). The output adapter24 is attached to a drainage tube, which in turn is operatively attachedto a reservoir for receiving effluent from the patient's stoma orfistula.

In another alternate embodiment, the inner tube member may be removableand interchangeable with a disposable cartridge or receptacle, such as areceptacle as described in U.S. Pat. No. 10,130,505, which is herebyincorporated herein by reference, in its entirety. In this embodiment,the disposable receptacle may be inserted into the outer frame memberand used to receive the effluent from the stoma or fistula while theostomy output diversion device is in place on a patient's body. Then,the disposable receptacle containing the effluent may be removed,sealed, and properly disposed of.

In another embodiment, as shown in FIGS. 13-19, an ostomy outputdiversion device includes a main body member 1 having a base ring 2,support members 16 attached to the base ring 2 on a first end thereof,and an outer frame 14 attached to the support members 16 on a second endthereof. An inner tube 3 is positioned on an inner portion of the outerframe member, and includes a first opening that fits over a stoma orfistula, where the first opening is located generally in a centralposition with respect to the base ring. A second opening is positionedon a lower portion of the inner tube, and is attached to a drainageadapter for receiving a drainage channel. As in other embodimentsdescribed herein, the other end of the drainage channel may be attachedto a pouch or reservoir for collecting effluent that flows outwardlyfrom the stoma or fistula, through the first opening in the adapter, anddownwardly through the second opening and into the drainage channel. Theouter frame 14 defines a centrally located opening on a distal endthereof, which is on an outer portion of the device on an opposite endfrom the base ring. The centrally located opening in the outer framemember allows a user or health care provider to look therethrough forpurposes of aligning the first opening on the adapter with the stoma orfistula on a patient's body. A removable concealing cap 28 may beaffixed to the inner tube member 3, as shown in FIGS. 13 and 14, tocover the centrally located opening. Additionally, adjustable tensionstraps 27 may be affixed to the removable concealing cap 28, and theadjustable tension straps may be used to 1) maintain the removableconcealing cap 28 in place on the inner tube member 3, and 2) to provideadditional tension to the inner tube member for a snug fit of the innertube against the skin next to a patient's stoma.

In an embodiment shown in FIG. 20, the concealing cap also includes anodor filter 29 that essentially serves two primary purposes: 1) itreleases gases trapped in a user's body as part of the natural digestiveprocesses, and 2) reduces or eliminates the odors that are associatedwith such gases. In embodiments that do not include an odor filter, anair valve or gas bleed valve may be incorporated into the system forreleasing gases. Odor filters are widely available commercially. Forexample, bamboo air purifier deodorizing carbon charcoal filters aresold commercially for use with diaper pails by Ninja Mama on Amazon.com.Bush Systems sells carbon odorless cloth diaper pail filters onAmazon.com, and Arm and Hammer sells nursery fresheners that includebaking soda and assorted scents. Any of these types of odor air filtersmay be used in conjunction with the present invention, as well as anyother suitable air filters.

It should be understood that other structural arrangements may be usedwithout departing from the spirit or scope of the present invention. Forinstance, it is conceived that one, two or more support members may beused, rather than the four support members shown in the Figures, inorder to provide easier access to the peristomal skin while the ostomyoutput diversion device is strapped onto a patient's body.

Although the present invention has been described in considerable detailwith reference to certain preferred versions thereof, other versions arepossible. Therefore, the spirit and scope of the appended claims shouldnot be limited to the description of the preferred versions containedherein. All features disclosed in this specification may be replaced byalternative features serving the same, equivalent or similar purpose,unless expressly stated otherwise. Thus, unless expressly statedotherwise, each feature disclosed is one example only of a genericseries of equivalent or similar features.

What is claimed is:
 1. An ostomy output diversion device comprising; abase ring; an outer frame member attached to said base ring; a hollowinner tube positioned inside said outer frame member; wherein said innertube includes a first opening for receiving effluent from a stoma andincludes a second opening for drainage of effluent; and said secondopening further including an inner tube adapter for receiving a drainagechannel.
 2. The ostomy output diversion device set forth in claim 1,wherein said inner tube is slidable in a longitudinal direction withrespect to said outer frame, so that said inner tube is linearlyadjustable toward and away from said stoma.
 3. The ostomy outputdiversion device set forth in claim 2, wherein the inner tube includes athird opening, said third opening being positioned opposite said firstopening for allowing access to the stoma.
 4. The ostomy output diversiondevice set forth in claim 3, further including a concealing cap forremovable attachment to said third opening of the inner tube forconcealing said stoma.
 5. The ostomy output diversion device set forthin claim 4, including elastic tension straps attached to said concealingcap to apply tension to and slide said inner tube toward the stoma,thereby creating a tight closure of said inner tube against the skinaround said stoma.
 6. The ostomy output diversion device set forth inclaim 2, including a tension lock to lock said inner tube into positionand retain the tension applied toward the skin around the stoma.
 7. Theostomy output diversion device set forth in claim 1, wherein saiddrainage channel is a tube.
 8. The ostomy output diversion device setforth in claim 1, wherein said drainage channel is a pouch.
 9. Theostomy output diversion device set forth in claim 7, wherein saiddrainage tube connects on a first end to the inner tube adapter, and ona second end to a reservoir for receiving and collecting effluent. 10.The ostomy output diversion device set forth in claim 1, furtherincluding a strap member that is connected to said base ring, whereinsaid strap member may be secured around a user's body in order to holdsaid ostomy output diversion device against said user's body.
 11. Theostomy output diversion device set forth in claim 1, further including astrap member attached to a strap ring, wherein said strap ring isremovably fitted over said outer frame member, and said strap member maybe secured around a user's body in order to hold said ostomy outputdiversion device against said user's body.
 12. The ostomy outputdiversion device set forth in claim 1, wherein said base ring isconstructed of a flexible material to conform to various body contours.13. The ostomy output diversion device set forth in claim 1, wherein theshape of said base ring is selected from the group consisting ofrectangular, octagonal, and oval.
 14. The ostomy output diversion deviceset forth in claim 4, wherein said concealing cap includes a filter forreducing odor.
 15. A method for capturing stoma output without use of anadhesive ostomy baseplate, comprising the steps of: providing an ostomyoutput diversion device for placement over a stoma, comprising a basering, a strap attached to said base ring; an outer frame member attachedto the base ring, an inner tube including a first opening for receivingeffluent from a stoma and a second opening for drainage of effluent;operatively attaching a drainage channel to said second opening of saidinner tube; positioning said strap member around the user's body;placing said base ring against the body around the stoma; and aligningsaid first opening of said inner tube to surround the stoma.
 16. Amethod for capturing stoma output without use of an adhesive ostomybaseplate, comprising the steps of: providing an ostomy output diversiondevice for placement over a stoma, comprising a base ring, a strapmember attached to said base ring, an outer frame member attached tosaid base ring, an inner tube including a first opening for receivingeffluent from a stoma and a second opening for drainage of effluent, anda third opening having a removable concealing cap; attaching a drainagechannel to said second opening of said inner tube; removing saidconcealing cap from the third opening; positioning said strap memberaround the user's body; placing said base ring against the body aroundthe stoma; aligning said first opening of the inner tube to surround thestoma; adjusting the elastic tension straps to achieve optimal pressureof the inner tube against the skin surrounding the stoma; and adjustingand securing said strap member for optimal fit.
 17. A method forcapturing stoma output without use of an adhesive ostomy baseplate,comprising the steps of: providing an ostomy output diversion device forplacement over a stoma, comprising a base ring, a strap member attachedto said base ring, an outer frame member attached to the base ring, alinearly adjustable inner tube member with a tension lock, said innertube further including a first opening for receiving effluent from astoma and a second opening for drainage of effluent; attaching adrainage channel to said second opening of said inner tube; positioningsaid strap member around the user's body; placing said base ring againstthe body around the stoma; aligning the inner tube to surround thestoma; sliding said inner tube toward the stoma to achieve optimalpressure of said inner tube against the skin surrounding the stoma;adjusting said tension lock to hold the inner tube in position; andadjusting and securing said strap member for optimal fit.